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| Product NDC Code | 55910-114 | ||||
|---|---|---|---|---|---|
| Drug Name | Night time sleep aid |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1248354 | ||||
| Application Number | M012 | ||||
| Labeler Name | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions take only one dose per day (24 hours) mL=milliliter keep dosing cup with product measure only with dosing cup provided. Do not use any other dosing device adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, sodium citrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Purpose
Information about the drug product’s indications for use.Purpose Nighttime sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Night Time Sleep Aid Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL POLYOXYL 40 STEARATE WATER SODIUM BENZOATE SACCHARIN SODIUM ANHYDROUS TRISODIUM CITRATE DIHYDRATE HIGH FRUCTOSE CORN SYRUP FD&C BLUE NO. 1 ALCOHOL FD&C RED NO. 40
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Compare to the active ingredient of ZzzQUIL®* Night Time Sleep Aid Diphenhydramine HCI 50 mg Non-habit forming Not for treating cold or flu ALCOHOL 10% Mixed Berry Flavor fl oz (mL) Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Procter & Gamble Company. ZzzQUIL® is a registered trademark of the Procter & Gamble Company. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
Package Label DOLLAR GENERAL HEALTH Night time Sleep Aid Diphenhydramine HCl 50 mg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information each 30 mL contains : sodium 23 mg store between 20-25ºC (68-77ºF). Do not refrigerate. protect from light
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-888-309-9030
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serous underling medical illness
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, avoid alcoholic beverages.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product, avoid alcoholic beverages. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serous underling medical illness If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API